The following data is part of a premarket notification filed by Tokuyama Dental Corporation with the FDA for Estelite Color.
| Device ID | K110178 |
| 510k Number | K110178 |
| Device Name: | ESTELITE COLOR |
| Classification | Material, Tooth Shade, Resin |
| Applicant | TOKUYAMA DENTAL CORPORATION 1425 K STREET, N.W. SUITE 1100 Washington, DC 20005 |
| Contact | Keith A Barritt |
| Correspondent | Keith A Barritt TOKUYAMA DENTAL CORPORATION 1425 K STREET, N.W. SUITE 1100 Washington, DC 20005 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-21 |
| Decision Date | 2011-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548190109234 | K110178 | 000 |
| 04548190109111 | K110178 | 000 |
| 04548190109128 | K110178 | 000 |
| 04548190109135 | K110178 | 000 |
| 04548190109142 | K110178 | 000 |
| 04548190109159 | K110178 | 000 |
| 04548190109166 | K110178 | 000 |
| 04548190109173 | K110178 | 000 |
| 04548190109180 | K110178 | 000 |
| 04548190109197 | K110178 | 000 |
| 04548190109203 | K110178 | 000 |
| 04548190109210 | K110178 | 000 |
| 04548190109227 | K110178 | 000 |
| 04548190109012 | K110178 | 000 |